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Rivista di Anestesia, Rianimazione, Terapia Antalgica e Terapia Intensiva
Minerva Anestesiologica 2012 Febbraio;78(2):168-75
Intraoperative intravenous administration of rFVIIa and hematoma volume after early surgery for spontaneous intracerebral hemorrhage: a randomized prospective phase II study
Imberti R. 1, Pietrobono L. 2, Klersy C. 3, Gamba G. 4, Iotti G. A. 5, Cornara G. 6 ✉
1 Direzione Scientifica, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy;
2 Servizio di Radiodiagnostica, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy;
3 Servizio di Biomedica e Statistica, Dipartimento di Ricerca, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy;
4 Dipartimento di Medicina Interna, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy;
5 Dipartimento di Anestesia e Terapia Intensiva, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy;
6 Dipartimento di Anestesia e Terapia Intensiva, Ospedale S. Croce e Carle, Cuneo, Italy
BACKGROUND: Surgery of spontaneous supratentorial intracerebral hemorrhage (ICH), especially if performed early, can be complicated by rebleeding, a condition that can worsen the outcome. We evaluated the effect of recombinant activated factor VII (rFVIIa) on postoperative rebleeding.
METHODS: In this randomized, open-label, single-blinded study, 21 patients with spontaneous supratentorial ICH diagnosed by computed tomography (CT) scan were treated with intravenous rFVIIa (100 mcg/Kg b.w., N=13) or placebo (N=8). Hematoma volume was assessed using CT scan immediately, 18-30 hours, and 5-7 days after hematoma evacuation. The primary endpoint was a hematoma volume at 18-30 hours after surgery. All CT scans were evaluated at one center by the same investigator who was unaware of the treatment. Hematoma volume was measured using dedicated software.
RESULTS: At baseline, the hematoma volume was 59.2±27.4 and 71.5±32.1 mL in the rFVIIa and placebo group, respectively. Hematoma evacuation resulted in significantly smaller ICH volumes that were similar in the rFVIIa and placebo group at 18-30 hours after surgery (15.9±14.2 mL and 18±15.1 mL, respectively; mean difference 2.1 mL, 95% confidence interval -12.1 to 16.2, P=0.76 (0.03 mL after adjustment for baseline value)). The frequencies of deep venous thrombosis, myocardial infarction, troponin I elevation and cerebral ischemia were similar in both groups.
CONCLUSION: In this pilot study, intraoperative, intravenous rFVIIa administration did not modify hematoma volume after early ICH surgery. However, the 95% CI was wide, which indicates considerable uncertainty. Therefore, our results do not disprove the potential benefit of rFVIIa administration, which could be shown in a larger study.